Drugs / Mirvetuximab Soravtansine
last change 10 days ago re-read 8 days ago

Mirvetuximab Soravtansine

Other / unclassified targets FOLR1

Developed for
primary peritoneal carcinoma · fallopian tube cancer · malignant epithelial tumor of ovary · fallopian tube carcinoma · ovarian cancer · ovarian carcinoma · endometrial cancer · peritoneal carcinoma
+15 more · peritoneum cancer · triple-negative breast carcinoma · breast cancer · endometrial serous adenocarcinoma · cancer · carcinosarcoma of the corpus uteri · endometrial clear cell adenocarcinoma · fallopian tube neoplasm · female breast carcinoma · neoplasm · pancreatic adenocarcinoma · uterine corpus cancer · ovarian epithelial tumor · ovarian neoplasm · peritoneal neoplasm
Investigated by
AbbVie · ImmunoGen, Inc. · GOG Foundation · Gynecologic Oncology Group · National Cancer Institute (NCI) · AGO Research GmbH
+16 more · Alessandro Santin · City of Hope Medical Center · Clovis Oncology, Inc. · Dana-Farber Cancer Institute · Duke University · European Network of Gynaecological Oncological Trial Groups (ENGOT) · Fudan University · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · M.D. Anderson Cancer Center · Merck Sharp & Dohme LLC · National Comprehensive Cancer Network · Ohio State University Comprehensive Cancer Center · Pheast Therapeutics · University of Alabama at Birmingham · University of Colorado, Denver · University of Oklahoma

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed progesterone-receptor positive breast cancer 3 milestones
Filed US (FDA) — progesterone-receptor positive breast cancer 2022-07-29

“FDA accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine (mirvetuximab) monotherapy” abbvie.com ↗

Filed US (FDA) — progesterone-receptor positive breast cancer 2022-05-23

“the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy” abbvie.com ↗

Filed US (FDA) — progesterone-receptor positive breast cancer 2022-03-29

“Submitted the biologics license application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine” abbvie.com ↗

“it has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab” abbvie.com ↗

Approved Indication not stated 5 milestones
Approved EU (EMA) Elahere — 2024-11-14 europa.eu ↗
Label expansion US (FDA) ELAHERE — 2024-03-22 fda.gov ↗
Filed US (FDA) ELAHERE platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer 2023-12-05

“FDA has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated approval of ELAHERE ®” abbvie.com ↗

Filed EU (EMA) ELAHERE platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer 2023-10-27

“EMA has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE ® )” abbvie.com ↗

Approved US (FDA) ELAHERE — 2022-11-14 fda.gov ↗

Trials 25

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06840886 Mar 2025 → Apr 2029 expected breast cancer, central nervous system neoplasm, cholangiocarcinoma, endometrial cancer +3 Pheast Therapeutics Recruiting No outcome recorded
Phase 1 NCT03552471 Jul 2018 → Jun 2022 BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, carcinosarcoma of the corpus uteri, endometrial serous adenocarcinoma +3 Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 1 NCT02996825 Oct 2017 → Feb 2024 fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma, triple-negative breast carcinoma +1 City of Hope Medical Center Completed No outcome recorded
Phase 1 NCT03045393 Apr 2017 → Feb 2018 triple-negative breast carcinoma Duke University Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT01609556 Jun 2012 → Mar 2018 neoplasm ImmunoGen, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02606305 Mar 2016 → Mar 2021 fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma ImmunoGen, Inc. Completed No outcome recorded
Phase 214 trials · 1 met primary
Phase 2 NCT07825753 Sep 2026 → Sep 2027 expected breast cancer, pancreatic adenocarcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT06890338 Nov 2025 → Feb 2030 expected fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma AbbVie Recruiting No outcome recorded
Phase 2 NCT07059845 Nov 2025 → Jan 2029 expected ovarian cancer AbbVie Recruiting No outcome recorded
Phase 2 NCT06682988 May 2025 → Jul 2026 overdue fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma AbbVie Recruiting No outcome recorded
Phase 2 NCT06365853 Jul 2024 → Jun 2026 overdue ovarian cancer AbbVie Recruiting No outcome recorded
Phase 2 NCT05887609 Oct 2023 → Jan 2029 expected fallopian tube carcinoma, ovarian cancer, peritoneal carcinoma University of Colorado, Denver Recruiting No outcome recorded
Phase 2 NCT05456685 Sep 2022 → Nov 2026 expected fallopian tube cancer, ovarian carcinoma, primary peritoneal carcinoma AbbVie Active not recruiting No outcome recorded
Phase 2 NCT05041257 Oct 2021 → Dec 2024 fallopian tube cancer, ovarian cancer, peritoneum cancer AbbVie Completed Met primary
Phase 2 NCT04274426 Oct 2021 → Dec 2025 overdue cancer AGO Research GmbH Active not recruiting No outcome recorded
Phase 2 NCT04606914 May 2021 → Jul 2027 expected fallopian tube neoplasm, ovarian cancer, peritoneum cancer University of Alabama at Birmingham Recruiting No outcome recorded
Phase 35 trials · 2 met primary · 1 missed
Phase 3 NCT05445778 Mar 2023 → Apr 2027 expected fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma AbbVie Active not recruiting No outcome recorded
Phase 3 NCT05622890 Aug 2022 → Apr 2023 fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 3 NCT04296890 Jul 2020 → Nov 2021 fallopian tube carcinoma, malignant epithelial tumor of ovary, peritoneal carcinoma ImmunoGen, Inc. Completed Met primary
Phase 3 NCT04209855 Dec 2019 → Mar 2023 fallopian tube carcinoma, malignant epithelial tumor of ovary, peritoneal carcinoma AbbVie Completed Met primary
Phase 3 NCT02631876 Mar 2016 → Jan 2019 fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma ImmunoGen, Inc. Completed Missed primary
Comparator or background therapy2 trials
Phase 3 NCT07218809 Comparator Dec 2025 → Nov 2028 expected ovarian epithelial tumor AstraZeneca Recruiting No outcome recorded
Phase 3 NCT07213804 Comparator Oct 2025 → Nov 2028 expected fallopian tube neoplasm, metastatic neoplasm, ovarian neoplasm, peritoneal neoplasm Eli Lilly and Company Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 52

DateIssuerRelease
2026-04-12 AbbVie Results AbbVie Showcases Late‑Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum‑Sensitive Ovarian Cancer (PSOC) at SGO 2026 abbvie.com ↗
Findings highlight mirvetuximab soravtansine's potential across the ovarian cancer treatment continuum.
2025-03-15 AbbVie Results ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients abbvie.com ↗
At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy.
2024-11-18 AbbVie Regulatory AbbVie Receives European Commission Approval of ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer abbvie.com ↗
ELAHERE is the first and only novel therapy approved in the European Union specifically for patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer
2024-09-20 AbbVie Regulatory AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer abbvie.com ↗
The CHMP's opinion is supported by results of the Phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year.
2024-09-09 AbbVie Results AbbVie Showcases Advancement of Solid Tumor Pipeline at ESMO 2024, with New Data in Tumor Types with High Unmet Needs abbvie.com ↗
The response rate seen with mirvetuximab soravtansine in PICCOLO highlights the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients.
2024-06-06 AbbVie Results AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer abbvie.com ↗
The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%).
2024-03-22 AbbVie Regulatory U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients abbvie.com ↗
ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial.
2023-12-05 AbbVie Regulatory FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer abbvie.com ↗
The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024 .
2023-11-02 AbbVie Results ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results abbvie.com ↗
In addition, we advanced the ELAHERE development program and are pleased to report that our PICCOLO trial in platinum-sensitive ovarian cancer has met the primary endpoint of objective response rate based on an interim efficacy assessment.
2023-10-27 AbbVie Regulatory ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer abbvie.com ↗
The acceptance of our MAA is another important regulatory milestone in the next chapter of ELAHERE’s story as we work diligently to deliver this new treatment option to patients with platinum-resistant ovarian cancer globally,
2023-09-28 AbbVie Results ELAHERE® Shows Overall and Progression-Free Survival Benefit Regardless of Prior PARPi Exposure or Prior Lines of Therapy in FRα-Positive Platinum-Resistant Ovarian Cancer abbvie.com ↗
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced findings from two subset analyses of the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE ® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC).
2023-06-04 AbbVie Results ELAHERE® Demonstrates 35% Reduction in the Risk of Disease Progression or Death Versus Chemotherapy in FRα-Positive Platinum-Resistant Ovarian Cancer abbvie.com ↗
Results from MIRASOL Also Show ELAHERE is the First Treatment to Demonstrate an Overall Survival Benefit in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer Compared to Chemotherapy

All press releases naming this drug 61 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Mirvetuximab Soravtansine ClinicalTrials.gov intervention name — accepted as the source's own label NCT03106077 ↗
21

NCT06682988 ↗

NCT03045393 ↗

NCT07059845 ↗

NCT05041257 ↗

NCT07218809 ↗

NCT02631876 ↗

NCT01609556 ↗

NCT02996825 ↗

NCT04606914 ↗

NCT04296890 ↗

Show 11 more sources

Known as IMGN853 “A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With...” NCT02631876 ↗
6

“Carboplatin (AUC5, d1) + Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV d1 x 6 cycles q21d, followed by subsequent monotherapy of Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV...” NCT04274426 ↗

“Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer” NCT03552471 ↗

“Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC)” NCT04606914 ↗

“Mirvetuximab Soravtansine (IMGN853)” NCT03045393 ↗

NCT03835819 ↗

NCT03832361 ↗

Known as MIRV “OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients...” PMID 40700855 ↗ Jul 2025
6

“Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate (ADC) consisting of the humanized anti-FRα monoclonal antibody M9346A covalently linked to the cytotoxic...” NCT07825753 ↗

“Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent...” PMID 33667670 ↗ Mar 2021

“Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC)” NCT04606914 ↗

“Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC.” NCT07059845 ↗

“Mirvetuximab Soravtansine (MIRV)” NCT07218809 ↗

NCT07213804 ↗

Known as mirvetuximab “Mirvetuximab soravtansine is a monoclonal antibody, called mirvetuximab, linked to a chemotherapy drug called DM4.” NCT02996825 ↗
Known as mirvetuximab soravtansine-gynx “BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody-drug conjugate with United States Food and Drug...” PMID 39617145 ↗ Nov 2024
3

“OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients...” PMID 40700855 ↗ Jul 2025

“Mirvetuximab soravtansine-gynx (MIRV), an antibody-drug conjugate, comprises a folate receptor alpha (FRα)-binding antibody and tubulin-targeting payload (maytansinoid DM4).” PMID 39082675 ↗ Jul 2024

NCT05887609 ↗

Action Deplete “may help find certain tumor cells and kill them without harming normal cells.” NCT03552471 ↗
Modality Other / unclassified “Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in patients with...” PMID 40700855 ↗ Jul 2025
Route Intravenous “Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.” NCT01609556 ↗
Target FOLR1 “Mirvetuximab attaches to FOLR1 positive cancer cells in a targeted way” NCT02996825 ↗